DOASENSE GmbH

DOASENSE GmbH specializes in urine testing systems. Their portfolio includes the DOASENSE Control Urines, which are used for calibration and quality assurance in diagnostic settings, and the DOASENSE Reader, a device designed to analyze urine samples for clinical assessment of urinary parameters. These products are intended for diagnostic use in healthcare environments.

DOASENSE GmbH is headquartered in Germany. The company’s location in Germany aligns with its compliance focus on European medical device regulations, particularly the EU In Vitro Diagnostic Regulation (IVDR).

DOASENSE’s devices are listed in the eudamed database, the official EU registry for in vitro diagnostic (IVD) medical devices. This listing ensures traceability and transparency regarding their compliance with EU regulatory requirements under the IVDR.

DOASENSE’s devices fall under Class A and IVD General classifications in the EU’s In Vitro Diagnostic Regulation (IVDR). Classification determines regulatory requirements, with Class A typically involving lower risk and streamlined compliance processes, while IVD General applies to diagnostic devices that assess biological samples like urine.